Most clinical studies pose the risk of minor discomfort, which lasts only a short time. However, some study participants experience complications that require medical attention. In rare cases, participants have been seriously injured or have died of complications resulting from their participation in trials of experimental therapies. The specific risks associated with a research protocol are described in detail in the informed consent document, which participants are asked to sign before participating in research. Also, a member of the research team explains the major risks of participating in a study and will answer any questions you have about the study. Before deciding to participate, carefully consider possible risks and benefits.
Possible benefits for volunteers:
Play an active role in their health care.
Gain access to research treatments before they are widely available.
Obtain medical care at health care facilities during the trial.
Help others by contributing to medical research.
Possible risks for volunteers:
There may be unpleasant, serious, or even life-threatening side effects to experimental treatment.
The experimental treatment may not be effective.
The protocol may require more time and attention than a non-protocol treatment, including trips to the study site, more treatments, hospital stays, or complex dosage requirements.